The latest CJEU referrals relating to SPCs Article 3(a) still not clear?

The latest CJEU referrals relating to SPCs  Article 3(a) still not clear?

The last few months have brought us two new CJEU referrals for disputes relating to SPCs – Decision 14 W (pat) 12/17 of the Bundespatentgericht (the “sitagliptin” reference) and Sandoz Limited & Hexal AG v G.D. Searle LLC & Janssen Sciences Ireland UC [2018] EWCA Civ 49 (the “darunavir” reference). Both of these cases concern Article 3(a) of the SPC Regulation, indicating that despite the number of CJEU decisions already relating to this subsection of the regulation (Medeva v Comptroller General (C-322/10), Eli Lilly v HGS (C-493/12), Actavis v Sanofi (C-443/12), Actavis v Boehringer (C-577/13) – the list goes on), there is still a need for further clarity.

Background

Article 3(a) requires that the subject of an SPC must be “protected by a basic patent in force”, but the question remains as to what this actually means. The Medeva decision (C-322/10) established that an SPC can only be granted for active ingredients “specified in the wording of the claims of the basic patent”. This ruling, however, appeared to open up uncertainty with regard to the meaning of “specified”. In Eli Lilly (C-493/12), the CJEU held that “specified” could include claims to a functional definition of the active ingredient rather than a structural formula, provided “the claims relate, implicitly but necessarily and specifically, to the active ingredient in question”. The CJEU also emphasized that a medicinal product which would infringe a patent is not necessarily protected by that patent for the purposes of the SPC Regulation. In other words, the test in not an “infringement” test.
 
Following this jurisprudence, the England and Wales Court has put forward their own test (first proposed by Arnold J in Actavis v Sanofi[2012] EWHC 2545 (Pat)), requiring the medicinal product for which an SPC is sought to “embody the inventive advance of the basic patent”. The CJEU has yet to consider whether this proffered test is appropriate for Article 3(a).
 

The sitagliptin reference

The first of the two new CJEU referrals under Article 3(a), from the German Court, relates to an SPC application for a medicinal product (sitagliptin) used in the treatment of diabetes. Sitagliptin, a dipeptidylpeptidase IV inhibitor, is covered by the basic patent in a functionally defined claim, but is not specifically disclosed in the patent, nor had it been developed at the priority date of the patent. The claim of the basic patent in question recites an “activity lowering effector of dipeptidylpeptidase IV (DP IV)-enzymatic activity for use in lowering the blood glucose level” in mammals. It was acknowledged by the referring court that sitagliptin was a DP-IV inhibitor.
 
The SPC application was initially rejected by the German Patent Office for not providing the specific active ingredient to the skilled person. The SPC applicant appealed the decision to the Bundespatentgericht (German Federal Patents Court). Here, the court distinguished between the CJEU jurisprudence and the “inventive advance” test proposed by the England and Wales Court, which they considered was not relevant for Article 3(a). The German court held that the requirements laid down by the CJEU in Medeva and Eli Lilly would only be met if the active ingredient in question is “specified in the claims in such a way that it can be identified as such and is actually provided to the skilled person.” Although the Bundespatentgericht ultimately agreed with the decision of the German Patent Office to refuse the SPC, they highlighted the fundamentally different views taken in the Member States with regard to Article 3(a) and the risk of permanent divergences in jurisprudence which would counteract the objective of the SPC regulation. The court therefore referred the following questions to the CJEU:
 
1. Is a product protected by a basic patent in force according to Article 3(a) of Regulation (EC) No 469/2009 only if it belongs to the protected subject-matter as defined by the claims and is thus provided to the person skilled in the art as a specific embodiment?
 
2. Is it therefore not sufficient for the requirements of Article 3(a) of Regulation (EC) No 469/2009 that the product in question meets the general functional definition of an active substance class as mentioned in the claims, but apart from that is not individualized as a specific embodiment of the teaching protected by the basic patent?
 
3. Is a product not protected according by Article 3(a) of Regulation (EC) No 469/2009 by a basic patent in force if it is covered by the functional definition contained in the claims, but was developed only after the filing date of the basic patent based on independent inventive activity?
 

The darunavir reference

The second CJEU referral is from the England and Wales Court of Appeal (Sandoz v G.D. Searle).[1] In brief, Sandoz sought to revoke Searle’s SPC for darunavir (Prezista) in order to clear the way for the launch of their generic darunavir product. The “basic patent” for the SPC covered darunavir through a Markush claim – a claim type that has yet to be considered by the CJEU in relation to Article 3(a) – but darunavir itself was not individually described within the patent. Sandoz argued that Article 3(a) of the SPC regulation was not satisfied. This case was heard at the England and Wales High Court in April 2017, where Arnold J found in favour of Searle, holding that, irrespective of the test used, darunavir was protected by the patent, as well as embodying the inventive advance of the patent.

On appeal, Floyd LJ reviewed the case law relating to Article 3(a) and particularly referred to the “spectrum of specificity” identified by Searle. This “spectrum” refers to the level of specificity by which an active ingredient must be defined in order to be “protected by a basic patent in force”. Floyd LJ considered the various tests established by case law, as well as those proposed by the parties involved, and stated that:

“In the case of a product with a single active ingredient and a patent with a claim which identifies a number of compounds by means of a Markush formula, all of which compounds embody the core inventive technical advance of the patent, the test should be whether the skilled person, considering the claims of the patent on the one hand and the structure of the product in question on the other, would immediately recognise that the active ingredient in question is one of those specified by the formula.” 

The judge considered that this test was satisfied in the present case, however held that it was not clear whether this was the correct approach in EU law and therefore referred the following question to the CJEU:

“Where the sole active ingredient the subject of a supplementary protection certificate issued under [the SPC Regulation] is a member of a class of compounds which fall within a Markush definition in a claim of the patent, all of which class members embody the core inventive technical advance of the patent, is it sufficient for the purposes of Article 3(a) of the SPC Regulation that the compound would, upon examination of its structure, immediately be recognised as one which falls within the class (and therefore would be protected by the patent as a matter of national patent law) or must the specific substituents necessary to form the active ingredient be amongst those which the skilled person could derive, based on their common general knowledge, from a reading of the patent claims?”

There is hope that, with these pending Article 3(a) referrals, further clarity may finally be achieved. We will be reporting further updates once there are any developments in this area.


[1] Kilburn & Strode LLP are part of the team for the respondents in this case.

For further information on this, please contact Claire Weston or your usual Kilburn & Strode advisor.

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